Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208624
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIEKIRA XR DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR EQ 200MG BASE;8.33MG;50MG;33.33MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/22/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208624Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208624Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2018 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208624Orig1s006ltr.pdf
11/09/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf
03/22/2017 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf
02/14/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s002ltr.pdf
03/22/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208624Orig1s001,208624Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/23/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208624s006lbl.pdf
11/09/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624Orig1s005ltr.pdf
03/22/2017 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf
03/22/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf
03/22/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s001s003lbl.pdf
02/14/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208624s002lbl.pdf
07/22/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208624s000lbl.pdf

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